Thermo Fisher SCIENTIFIC LBL-60110 Accula Flu A-Flu B Control Kit Instructions

Thermo Fisher SCIENTIFIC LBL-60110 Accula Flu A-Flu B Control Kit

Intended use

The Accula™ Flu A/Flu B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A/Flu B Test.

Product Description

The Accula™ Flu A/Flu B Control Kit provides swabs coated with dried, inactivated influenza A or influenza B virus. The level of influenza A or influenza B virus applied to the swab is sufficient to provide a positive result when used with the Accula™ Flu A/Flu B Test. The Accula™ Flu A Positive/Flu B Negative Swab acts as a negative control for influenza B; the Accula™ Flu B Positive/Flu A Negative Swab serves as a negative control for influenza A. When used for quality control with the Accula™ Flu A/Flu B Test, these controls are useful as an aid in verifying test and operator performance.

Materials provided

Each Accula™ Flu A/Flu B Control Kit contains the following:

• Accula™ Flu A Positive/Flu B Negative Swab (yellow shaft, 3 swabs)—Contains inactivated influenza A virus dried onto a swab.
• Accula™ Flu B Positive/Flu A Negative Swab (blue shaft, 3 swabs)—Contains inactivated influenza B virus dried onto a swab.
• Electronic documentation instructions

Storage

• Accula™ Flu A/Flu B Control Kit must be stored at 15°C to 30°C (59°F to 86°F).
• Swabs should be kept in the sealed pouch until testing.

Materials provided separately

• Accula™ Dock
  • Catalog No. D2000
  • Catalog No. D2002 (Contact your sales representative for information on ordering this item)
• Accula™ Flu A/Flu B Test—Catalog No. FAB1100CW

Warnings and precautions

• For in vitro diagnostic use.
• Federal law restricts sale of this product to or on the order of a licensed practitioner.
• To be used in conjunction with the Accula™ Flu A/Flu B Test and the Accula™ Dock.
• Do not use the controls past their expiration date.
• Inactivated influenza A and influenza B viruses are used to make the control swabs. However, control swabs and used cassettes should be handled as though they could transmit disease. Observe established precautions against microbial hazards during use and disposal.
• Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when handling samples.
• Do not use any damaged kit contents.
• Do not touch the heads of the control swabs. Cross-contamination may occur due to the high sensitivity of the test.
• Follow proper infection control guidelines for handling all specimens, control swabs, and related items. Properly dispose of all contaminated waste according to federal, state, and local requirements.
• Not for patient use.
• Swabs stored in the foil pouch at 15°C to 30°C (59°F to 86°F) are stable until the expiration date printed on the pouch.

Instructions for use

Process the Accula™ Flu A/Flu B Control Kit swabs as you would a patient sample in accordance with the procedure for the Accula™ Flu A/Flu B Test. Read the instructions for use provided with the Accula™ Flu A/Flu B Test before using the Accula™ Flu A/Flu B Control Kit.

Expected results

The following results are expected when using the control swabs with the Accula™ Flu A/Flu B Test:

• Accula™ Flu A Positive/Flu B Negative Swab should yield a positive result for Flu A and a negative result for Flu B.
• Accula™ Flu B Positive/Flu A Negative Swab should yield a positive result for Flu B. and a negative result for Flu A.

Disposing of material

Discard hazardous or biologically contaminated materials according to your institution’s practices. Discard all materials in a safe and acceptable manner that is in compliance with all country, state, and local requirements.

Technical support

If external QC testing fails, repeat the test using new control swabs, reagents, and test cassettes, or contact Technical Support before continuing with further samples.
Email: techsupport@thermofisher.com

Telephone: 1-800-955-6288, option 2
For the latest service and support information at all locations, or to obtain Certificates of Analysis or Safety Data Sheets (SDSs; also known as MSDSs), go to thermofisher.com/support.

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Mesa Biotech, Inc. | 6190 Cornerstone Court East, Suite 220 | San Diego, CA 92121 USA

The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.
Revision history: Pub. No. LBL-60110

A

|

5 May 2022

| •    Supersedes LBL-60016.

•    Initial document release with new publication number, using the latest Thermo Fisher Scientific template, with associated logos, trademarks, and format.

Important Licensing Information:

These products may be covered by one or more Limited Use Label Licenses. By use of these products, you accept the terms and conditions of all applicable Limited Use Label Licenses.
©2022 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.

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References

• Thermo Fisher Scientific - AU
• Contact Us | Thermo Fisher Scientific - US
• Help and Support | Thermo Fisher Scientific - UK
• D2000 | Thermo Fisher Scientific

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